THRIVE-CAR-T Digital App (THRIVE-CAR-T)

Randomized Controlled Trial of a Supportive Care Digital Application (THRIVE-CAR-T) for Patients Receiving CAR-T Cell Therapy

The goal of this clinical trial is to learn if a digital mobile application called THRIVE-CAR-T is helpful for the care of patients undergoing CAR-T cell therapy. The main question[s] it aims to answer are whether the THRIVE-CAR-T app is feasible and acceptable to patients.

Study Overview

• Status: Recruiting
• Conditions: CAR T-Cell Therapy
• Intervention / Treatment: Behavioral: THRIVE-CAR-T

Detailed Description

This pilot randomized controlled trial aims to examine the feasibility, acceptability, and preliminary effects of a supportive care digital app (THRIVE-CAR-T) versus usual care in patients receiving chimeric antigen receptor T-cell therapy (CAR-T). The primary objective of the study is to determine if THRIVE-CAR-T is feasible and acceptable to patients. The exploratory objective is to assess the preliminary effects of THRIVE-CAR-T for improving patient-reported quality of life (QOL), psychological distress, and self efficacy.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick C Johnson, MD; Phone Number: 6177244000; Email: pcjohnson@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Patrick C Johnson, MD; Phone Number: 6177244000; Email: pcjohnson@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years or older
2. Ability to understand English
3. Diagnosis of a hematologic malignancy
4. Receiving autologous CAR-T at MGH with an FDA approved cellular therapy product

Exclusion Criteria:

1. Impaired cognition or uncontrolled mental illness that prohibits the ability to provide informed consent based on the oncology clinician assessment
2. Already participating in another supportive care clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Usual care at our institution involves a teaching visit with a nurse navigator and written handouts.
Experimental: THRIVE-CAR-T plus usual care; Patients receiving the THRIVE-CAR-T intervention will receive usual care and will use the THRIVE-CAR-T digital application on an iPad when planned to receive CAR-T.	Behavioral: THRIVE-CAR-T; The intervention will begin several weeks prior to CAR-T cell therapy and will continue up until 30 days post CAR-T cell therapy. THRIVE-CAR-T is an educational and interactive digital application on an iPad for patients as they navigate receiving CAR-T. THRIVE-CAR-T is self-administered and provides education about the CAR-T cell therapy process, with several features to promote coping skills training informed by various well-established supportive psychotherapy strategies (e.g., cognitive behavior therapy, mindfulness, positive psychology), engagement, and health behavior change including gamification strategies, videos of patients who received CAR-T, and optional content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Feasibility is defined based on the rate of patient enrollment. THRIVE-CAR-T will be deemed feasible if rates of enrollment are >= 60%, and among those enrolled and randomized to THRIVE-CAR-T, 60% complete 3 out of 5 modules. For patients who either die prior to the end of the intervention or are admitted to the intensive care unit (ICU), the latter definition of feasibility will be completion of 60% of expected modules at the time of clinical deterioration.	Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	THRIVE-CAR-T will be deemed acceptable if at least 80% of patients report THRIVE-CAR-T is acceptable based upon a rating of "Somewhat comfortable" or "Very comfortable" on a 4 point Likert scale single question when asked about whether they feel comfortable with the intervention.	Through study completion, an average of 2 years
Quality of life	Quality of life will be assessed using the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-G is a 27-item measure consisting of four subscales assessing well-being across four domains (physical, functional, emotional, and social) during the preceding week. Scores range from 0 to 108, with higher scores indicating better QOL	From enrollment until 90 days after CAR-T cell therapy
Anxiety symptoms	Anxiety symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure with two separate subscales to evaluate symptoms of anxiety and depression. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression.	From enrollment until 90 days after CAR-T cell therapy
Depression symptoms	Depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure with two separate subscales to evaluate symptoms of anxiety and depression. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression	From enrollment until 90 days after CAR-T cell therapy
PTSD symptoms	PTSD symptoms will be assessed using the Post-traumatic Stress Disorder Checklist-Civilian Version, a17-item PTSD Checklist that evaluates the severity of PTSD symptoms. Scores range from 0-68. Higher scores on the PCL indicate worse PTSD symptoms, with a cutoff of 32 or greater denoting clinically significant PTSD symptoms	From enrollment until 90 days after CAR-T cell therapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy	Self-efficacy will be assessed using the Cancer Self-efficacy Scale (CASE), a commonly utilized measure to assess patients' confidence in managing the impact of their illness. Scores range from 12-48, with higher scores denoting better self-efficacy.	From enrollment until 90 days after CAR-T cell therapy
Coping	Coping will be assessed using the Measure of Current Status Part A (MOCS-A), a 13-item measure to assess the self-perceived status on several coping skills such as relaxation, cognitive restructuring, and assertive communication. Scores range from 0-52, wither scores denoting greater coping ability.	From enrollment until 90 days after CAR-T cell therapy
Knowledge about CAR-T cell therapy	Knowledge will be assessed with a Knowledge assessment, where patients will complete nine true/false questions and one multiple choice question to assess patients' knowledge regarding CAR T-cell therapy, with each question worth 1 point for a possible total of 10 points, as done in prior work. Scores range from 0-10, with higher scores denoting greater knowledge.	From enrollment until 90 days after CAR-T cell therapy
Usability of THRIVE-CAR-T	Usability of THRIVE-CAR-T will only be assessed in those randomized to THRIVE-CAR-T). We will use the system usability scale at day 30 to assess the usability of THRIVE-CAR-T. Scores range from 0-100, with higher scores denoting greater usability.	From enrollment until 30 days after CAR-T cell therapy

Collaborators and Investigators

• Sponsor: Patrick C. Johnson, MD

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; mobile application; digital application; car-t cell therapy
• Other Study ID Numbers: 24-428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified data will be made available upon email request to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No